Description:
This role is responsible for conducting in-process and final product quality analyses and inspections in strict compliance with established standards and regulatory requirements within a global pharmaceutical manufacturing environment. The incumbent interprets and evaluates analytical results in terms of accuracy and precision against predetermined specifications to ensure product integrity and patient safety. The position identifies ongoing quality issues and takes proactive measures to prevent potential production problems, contributing to a culture of continuous quality improvement. It applies various measuring devices, testing equipment, and prescribed methodologies to accept or reject products based on defined quality criteria. The role audits and monitors manufacturing processes and outputs against both internal and regulatory standards to uphold compliance across all quality control activities. It tests random samples of finished goods to verify conformance with quality specifications and regulatory expectations. The position reports manufacturing process deviations and defects in finished goods to the appropriate quality and production stakeholders. It supports the organization's overarching commitment to delivering safe, effective, and compliant pharmaceutical products to patients and global markets.
Essential Functions:
- Perform in-process and final product quality analyses and inspections in accordance with established specifications and regulatory requirements
- Interpret and evaluate analytical results for accuracy and precision against predetermined quality standards
- Identify ongoing quality issues and implement preventive measures to avoid potential production disruptions
- Operate various measuring devices and testing equipment using predetermined methods and prescribed specifications to accept or reject products
- Test random samples of finished goods to verify compliance with quality specifications
- Report manufacturing process deviations and defects in finished goods to relevant stakeholders in a timely manner
- Support continuous improvement initiatives by suggesting enhancements to quality processes and testing methodologies
Maintain accurate and complete documentation of all quality testing activities in compliance with GMP and GLP requirements
Additional Responsibilities:
